Breast Cancer MetastaticNCT06873997
Real World Study of Bone Metastases in Patients with Advanced Breast Cancer
An observational study of Breast Cancer Metastatic, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
By analyzing the clinical data of patients with advanced breast cancer with bone metastasis admitted to our center from January 1, 2021 to February 28, 2023, this study aims to understand the real-world clinical diagnosis and treatment of breast cancer with bone metastasis, including the epidemiology of bone… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Metastatic
- How many people
- 737 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients admitted to Zhejiang Cancer Hospital from January 1, 2021 to February 28, 2023 were included
Who may be able to join
- Age ≥18y;
- Advanced breast cancer is clearly diagnosed;
- Imaging or pathology confirmed at least 1 bone metastasis;
- No history of other malignant tumors at the time of initial diagnosis;
- The physical status score of Eastern Tumor Collaboration Group (ECOG) was ≤2 points;
- Complete clinical and follow-up data.
Who cannot join
- Exclusion is defined as meeting 1 of the following exclusion criteria:
- Patients with other malignant tumors;
- History of hyperthyroidism and hypothyroidism, abnormal parathyroid function;
- History of bone metabolic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Occurrence Time of Bone Metastasis and Disease Treatment Patterns in Patients with Breast Cancer Bone Metastasis: a Retrospective Study from China
By analyzing the clinical data of patients with advanced breast cancer with bone metastasis admitted to our center from January 1, 2021 to February 28, 2023, this study aims to understand the real-world clinical diagnosis and treatment of breast cancer with bone metastasis, including the epidemiology of bone metastasis, screening and diagnosis methods, selection of clinical treatment methods, and occurrence of SRE. To explore the risk factors related to bone metastasis-free survival (BMFI). In addition, we will explore the use of quantitative analysis of CT values to evaluate bone metastases of breast cancer, aiming to provide a new method for imaging quantitative efficacy evaluation of bone metastases.
Read the detailed description
The specific contents of our research include the basic information of breast cancer patients with bone metastasis in the early stage, neoadjuvant therapy, surgery and postoperative pathology, and adjuvant therapy; The time and location of recurrence and metastasis, treatment plan, and information related to bone metastasis include time, location, diagnosis method, treatment, occurrence of SRE, and changes in CT values of bone lesions before and after drug treatment. The objective is to understand the risk factors of bone metastasis-free survival (BMFI) of breast cancer patients with bone metastases in the real world, provide evidence and data for clinical accurate screening, observe the CT value changes of bone lesions through imaging (CT quantitative), and explore a new method for evaluating the efficacy of bone metastases.
- Conditions
- Breast Cancer Metastatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone metastasis-free interval (BMFI) of breast cancer patients with bone metastasis
Bone metastasis-free interval (BMFI) is the time between diagnosis of breast cancer and the onset of bone metastases
Measured: From the diagnosis of breast cancer to the occurrence of bone metastasis，assessed up to 100 months
Secondary outcomes (4)
Number of participants with Clinical features of bone metastasis
Clinical characteristics of patients with bone metastasis include age, menstrual status, body mass index (BMI), presence or non-presence of underlying disease, tumor location, primary tumor size, number of lymph node metastases, TNM stage, pathologic type, histological classification, vascular thrombus invasion, estrogen receptor (ER) status, progesterone receptor (PR) status, and other factors. Human epidermal growth factor receptor-2 (HER-2) expression, Ki-67 level, whether chemotherapy and radiotherapy, recurrence and metastasis time, recurrence and metastasis site.
Measured: From the diagnosis of breast cancer to the conclusion of the study period，assessed up to 100 months
Changes of CT values of bone lesions before and after treatment with bone protective drugs
CT value selection method: A professional physician manually selected a region of interest (ROI) for a single bone metastatic lesion, and recorded the mean value of CT value, which was expressed in Hounsfield units (HU). The ROI difference of the same bone metastasis before and after treatment was not more than ±10mm2
Measured: From the start of treatment with bone care drugs to 1 year
Patterns of bone metastasis in the center
The time of bone metastasis were included
Measured: rom the diagnosis of breast cancer to the occurrence of bone metastasis,assessed up to 100 months
Occurrence of bone-related events
Skeleton-relative Events (SREs) include pathological fractures, spinal cord compression, bone surgery, and radiation therapy
Measured: From the diagnosis of breast cancer to the occurrence of bone-related events，assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Jan 2021
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 737 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xiaojia, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873997
- Sponsor's protocol ID
- IRB-2023-692
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Occurrence Time of Bone Metastasis and Disease Treatment Patterns in Patients with Breast Cancer Bone Metastasis: a Retrospective Study from China
- ClinicalTrials.gov ID
- NCT06873997
- Acronym / sponsor ID
- IRB-2023-692
- Conditions
- Breast Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 737 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By analyzing the clinical data of patients with advanced breast cancer with bone metastasis admitted to our center from January 1, 2021 to February 28, 2023, this study aims to understand the real-world clinical diagnosis and treatment of breast cancer with bone metastasis, including the epidemiology of bone metastasis, screening and diagnosis methods, selection of clinical treatment methods, and occurrence of SRE. To explore the risk factors related to bone metastasis-free survival (BMFI). In addition, we will explore the use of quantitative analysis of CT values to evaluate bone metastases of breast cancer, aiming to provide a new method for imaging quantitative efficacy evaluation of bone metastases.
Detailed description
The specific contents of our research include the basic information of breast cancer patients with bone metastasis in the early stage, neoadjuvant therapy, surgery and postoperative pathology, and adjuvant therapy; The time and location of recurrence and metastasis, treatment plan, and information related to bone metastasis include time, location, diagnosis method, treatment, occurrence of SRE, and changes in CT values of bone lesions before and after drug treatment. The objective is to understand the risk factors of bone metastasis-free survival (BMFI) of breast cancer patients with bone metastases in the real world, provide evidence and data for clinical accurate screening, observe the CT value changes of bone lesions through imaging (CT quantitative), and explore a new method for evaluating the efficacy of bone metastases.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients admitted to Zhejiang Cancer Hospital from January 1, 2021 to February 28, 2023 were included
Key inclusion criteria (6 listed)
- Age ≥18y;
- Advanced breast cancer is clearly diagnosed;
- Imaging or pathology confirmed at least 1 bone metastasis;
- No history of other malignant tumors at the time of initial diagnosis;
- The physical status score of Eastern Tumor Collaboration Group (ECOG) was ≤2 points;
Key exclusion criteria (4 listed)
- Patients with other malignant tumors;
- History of hyperthyroidism and hypothyroidism, abnormal parathyroid function;
- History of bone metabolic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone metastasis-free interval (BMFI) of breast cancer patients with bone metastasis
Time frame: From the diagnosis of breast cancer to the occurrence of bone metastasis，assessed up to 100 months
Bone metastasis-free interval (BMFI) is the time between diagnosis of breast cancer and the onset of bone metastases
4 secondary outcomes
Number of participants with Clinical features of bone metastasis
Time frame: From the diagnosis of breast cancer to the conclusion of the study period，assessed up to 100 months
Changes of CT values of bone lesions before and after treatment with bone protective drugs
Time frame: From the start of treatment with bone care drugs to 1 year
Patterns of bone metastasis in the center
Time frame: rom the diagnosis of breast cancer to the occurrence of bone metastasis,assessed up to 100 months
Occurrence of bone-related events
Time frame: From the diagnosis of breast cancer to the occurrence of bone-related events，assessed up to 100 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Metastatic, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone metastasis-free interval (BMFI) of breast cancer patients with bone metastasis (time frame: From the diagnosis of breast cancer to the occurrence of bone metastasis，assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.